R&D Training Sr. Analyst
3170 Porter Drive Palo Alto, CA 94304 US
Job Description
Job Description:
The R&D Training Sr. Analyst/External TC is responsible for supporting the maintenance of training requirements/accounts of all external R&D vendors/FSPs /direct PV Service Providers. This role will liaise with R&D Training management to support the maintenance of assigned training plans and will also work closely with GxP Training in Quality Systems. The R&D Sr. Analyst/External TC may participate in inspection readiness activities and may support inspection and audit training SMEs. The R&D Training Sr. Analyst/External TC may assist in special projects as assigned by the R&D Training department management.
Essential Functions:
- Work closely with GCM and PVAM Business Process Owners (BPOs) to support development and maintenance of on-the-job training and related curricula for direct PV Service Providers.
- Responsible for facilitating the creation of Learn accounts and assignment of certifications for external PV Service providers.
- Ensuring PV Service Provider(s) are provided with the relevant training in order to execute their PV activities, enabling robust compliance with regulatory authorities and business partner obligations for AE handling and ICSR management.
- Collaborates with GCM and PVAM to ensure high quality and compliance with standards and conventions for process and training activities of case management vendors.
- Work with the GCM and PVAM BPOs, to ensure timely issue escalation if/as necessary and identification of continuous improvement activities.
- Streamline GCM and PVAM communication across GCM and PVAM, including collaboration with PV Service Provider(s) as appropriate to ensure consistency and timeliness of communication regarding change to processes, conventions, and training.
- Assignment/Removal of Job Roles for R&D external vendors/FSPs/direct PV Service Providers
- Monitor R&D P&T mailbox and respond to inquiries related to external vendors/FSPs/direct PV Service Providers
- Tracking of external vendor/FSP/direct PV Service Providers training assignments and personnel
- Daily review of training reports as needed
- Complete requests to create/maintain departmental external vendor/FSP job roles/direct PV service providers
- Support periodic training review
- Maintenance of assigned GXP training accounts
- Assist R&D Training management in creating and maintaining assigned training matrices
- Participate in ongoing audit/inspection readiness activities and provide support for audits/inspections
- Performs other activities as directed by R&D Training management
- Knowledge of GxP regulations
- Familiarity with health authority regulations
- Knowledge of the conduct of clinical trials
- Experience with quality management activities
- Experience with Electronic Document Management Systems
- Experience with developing and maintaining training matrices
- Proficiency in all Microsoft Office applications
- Organize, maintain, and distribute cross-functional meeting minutes and agendas as needed
- Ability to demonstrate values and strong organizational competencies
Required Knowledge, Skills, and Abilities:
- 2+ years’ experience working in a pharmaceutical industry role preferred
- Ability to multi-task and shift priorities
- Must be self-motivated and detail oriented.
- Flexibility to work outside of normal working hours or on-call arrangements
- Ability to communicate effectively, both verbally and in writing
- Good collaboration and networking skills
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